The Correlation Between Red Cell Transfusion and Complications of Prematurity

NCT07123948 | Not Yet Recruiting

• 1 other identifier: 003-05/24-01/150
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity. The main questions it aims to answer are:

• Do premature infants who receive blood transfusions within their first month of life have a higher risk of early prematurity complications, such as retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and intraventricular haemorrhage?
• Do premature infants who receive blood transfusions during their first month of life have worse neurological and neurodevelopmental outcomes than those who do not? The first part of the study is retrospective, using data collected from participants' histories. The second part is prospective, evaluating neurological and neurodevelopmental outcomes at the age of six years.

Conditions

Retinopathy of Prematurity (ROP); Bronchopulmonary Dysplasia (BPD); Enterocolitis, Necrotizing; Intraventricular Hemorrhage Neonatal

Keywords

Infant, Premature;; Erythrocyte Transfusion; Neurodevelopmental Disorder

Outcome Measures

Primary Outcomes (4)

• Motor function at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

  The outcome measure is the motor function of premature infants (less than 32 weeks of gestation) at the age of 6 years who received erythrocyte transfusion in the neonatal period. The aim is to identify the proportion of participants with normal, mildly impaired, moderately impaired, or severely impaired motor function. The Gross Motor Function Classification System (GMFCS) will be used to assess motor function. GMFCS is a standardized classification tool used to evaluate and describe motor function levels in children with cerebral palsy. It was created to offer a dependable framework for understanding restrictions in gross motor skills in children of different age groups. If The GMFCS score is 0, motor function is normal. Cerebral palsy will be classified as mild if the GMFCS score is 1, moderate if the GMFCS score is 2, and severe if the GMFCS score is 3 or higher. On the GMFCS scale, the minimum value is 0, and the maximum value is 5. The higher score means a worse outcome.

  From enrollment to the end of the neurologic assessment at 4 weeks.

• Hearing assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

  The aim is to identify the proportion of participants with normal and impaired hearing function. Hearing assessment depends on whether the child requires hearing aids. If the child needs hearing aids, the score will be 1; if not, the score will be 0. The minimum value is 0, and the maximum value is 1. A higher score means a worse outcome.

  From enrollment to the end of the hearing assessment at 4 weeks.

• Visual assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

  The aim is to identify the proportion of participants with normal and impaired visual function. Visual assessment depends on whether the child requires visual aids. If the child needs visual aids, the score will be 1; if not, the score will be 0. The minimum value is 0, and the maximum value is 1. A higher score means a worse outcome.

  From enrollment to the end of the hearing assessment at 4 weeks.

• Neurodevelopmental outcome of premature infants who received erythrocyte transfusion compared to those who did not

  Neurodevelopmental assessment will be conducted using the Wechsler Intelligence Scale for Children (WISC-IV). It is a clinical tool for evaluating the intelligence of children aged 6 to 16 years and 11 months. The test includes 15 subtests - 10 core and 5 supplementary. Intellectual functioning in specific cognitive areas is also represented by four composite scores: the Verbal Comprehension Index (VCI), the Perceptual Reasoning Index (PRI), the Working Memory Index (WMI), and the Information Processing Speed Index (PSI). The total test score (UIQ) is calculated based on the sum of scaled scores across the 10 core subtests. The resulting IQ scores are categorized as follows: 69 and below is extremely low; 70 to 79 is borderline; 80 to 89 is low average; 90 to 109 is average; 110 to 119 is high average; 120 to 129 is superior; and 130 and above is very superior. Minimum value is 40, and the maximum value is 200. The higher score means a better outcome.

  From enrollment to the end of the neurologic assessment at 4 weeks.

Study Arms (1)

Assesment of the neurological and neurodevelopmental outcome at the age of six

All premature infants (less than 32 weeks of gestation) will be neurologically assessed at the age of six. Also, their neurodevelopmental outcome will be assessed at the age of six using the Wechsler Intelligence Test.

Diagnostic Test: Wechsler Intelligence Test, performed by educated psychologists

Interventions

Wechsler Intelligence Test, performed by educated psychologists DIAGNOSTIC_TEST

At the age of six, parents of children who meet the inclusion criteria will receive a notification about the study from the responsible paediatrician. If they agree to participate, they will sign an informed consent form. They will then be invited to the clinic for a neurological and neurodevelopmental assessment. The neurological examination will be conducted by the principal investigator or collaborators who are paediatric specialists. The neurodevelopmental evaluation will be performed by a qualified psychologist using the Wechsler Intelligence Test. The Wechsler Intelligence Test for Children - Fourth Edition is a clinical tool for measuring the intelligence of children aged 6 to 16 years and 11 months. It assists in identifying specific learning difficulties, hyperactivity disorder, speech and language challenges, and intellectual impairments. The test comprises 15 subtests.

Assesment of the neurological and neurodevelopmental outcome at the age of six

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be identified and selected by the primary care paediatricians in Primorsko-Goranska, Istarska, and Ličko-Senjska County (western part of Croatia)

You may qualify if:

• all children born as premature infants \<32. weeks of gestation in Clinical Hospital Centre Rijeka from June 2018. to December 2021. (and who will be on September 2025. six years old)
• signed informed consent

You may not qualify if:

• genetic syndromes, severe congenital anomalies

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Study Sites (1)

Clinical Hospital Centre Rijeka, Department of Paediatrics

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

MeSH Terms

Conditions

Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Enterocolitis, Necrotizing; Premature Birth; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Officials

• senada šerifi

  Clinical Hospital Centre Rijeka, Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Lah Tomulić

CONTACT

+385992015885; kristina.lah.tomulic@medri.uniri.hr

senada šerifi

CONTACT

senada.serifi@medri.uniri.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)